PregnancyPhase 3DHANINCT01580345
Effect of Docosa-Hexanoic Acid (DHA) Supplements During Pregnancy on Newborn Outcomes in India.
A Phase 3 study testing Docosa-hexaenoic acid (DHA) in people with Pregnancy, run by Centre for Chronic Disease Control, India at 1 site in India.
Trial summary
The 'DHANI randomized controlled trial" seeks to examine the effects of prenatal DHA supplementation on newborn anthropometry where in healthy pregnant will be assigned to receive either 400 mg of DHA or a placebo daily from ≤20 weeks gestation through delivery. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Docosa-hexaenoic acid (DHA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2015to 9 Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 35 year old pregnant women (singleton) at <=20 weeks of gestation (calculated from the LMP by study physician).
- Willing to participate in the study and perform all measurements for self, husband and the offspring including anthropometry, dietary assessment, questionnaires and biological samples (blood and breast milk).
- Willing to provide signed and dated informed consent.
Who cannot join
- Women allergic (if aware) to any of the test products.
- Women at high risk for hemorrhagic bleeding, clotting (if aware).
- Women with high-risk pregnancies (history and prevalence of pregnancy complications, including abruptio placentae, preeclampsia, pregnancy-induced hypertension, any serious bleeding episode in the current pregnancy, and/ or physician referral); and/or diagnosed chronic degenerative disease(s) such as diagnosed heart disease, cancer, stroke or diabetes (as omega-3 could raise blood sugar and lower insulin production).
- Women consuming omega-3 supplements or having used these in 3 months preceding the intervention period.
- Reported participation in another biomedical trial 3 months before the start of the study or during the study (not to get the results of the present study contaminated).
Trial locations and contacts
1 site in 1 country.
India1 site
KLEUs Jawaharlal Nehru Medical College- Prabhakar Kore Charitable Hospital
Belagavi, Karnataka, 590010
About this study
Official title: Effect of Docosa-Hexanoic Acid (DHA) Supplements During Pregnancy on Newborn Outcomes in India (DHANI)
The 'DHANI randomized controlled trial" seeks to examine the effects of prenatal DHA supplementation on newborn anthropometry where in healthy pregnant will be assigned to receive either 400 mg of DHA or a placebo daily from ≤20 weeks gestation through delivery.
Read the detailed description
A double-blinded, randomized, placebo controlled trial would be conducted among pregnant women in India to test the effectiveness of supplementing pregnant Indian women with 400 mg/d algal DHA compared to placebo from mid-pregnancy through delivery. Eligible participants would be randomized to receive either 400 mg of DHA or a placebo baseline measures would be taken before the enrollment of the participant in the study. This study would assess the effect of maternal DHA supplementation on:
- New born anthropometry (birth weight, length and head circumference)
- New born APGAR score
- Conditions
- Pregnancy
- Being tested
- Docosa-hexaenoic acid (DHA), Placebo
- Keywords
- DHA, Omega 3 fatty acid, Decosa hexaenoic acid, Pregnancy, Newborn outcome, Supplementation, Birth size, gestational age, India, Randomized controlled trial, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docosa-hexaenoic acid (DHA)Dietary supplement
Also called DHA, Omega 3 fatty acid
400 mg/day of Docosa-hexaenoic Acid (algal DHA) will given to the pregnant women (in the active group) from ≤20 weeks of gestation through delivery.
PlaceboDietary supplement
Also called Corn/Soy oil
400 mg/day of placebo (corn/soy oil) will be given to the pregnant women from ≤20 weeks of gestation through delivery.
| Study group | Role | What they receive |
|---|---|---|
| Docosa-hexaenoic Acid (DHA) | Active comparator | Not described Receives: Dietary Supplement: Docosa-hexaenoic acid (DHA) |
| Placebo | Placebo comparator | Corn-Soy Oil Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn anthropometry.
Measures for new born anthropometry would include birth weight, length and head circumference
Measured: At delivery
Secondary outcomes (3)
Gestational age
Measured: At delivery
New born APGAR Score
APGAR : Appearance, Pulse, Grimace, Activity, Respiration scores
Measured: At delivery (1 min and 5 mins)
Unfavorable pregnancy outcomes
Still births, low birth weight babies and preterm babies
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startDec 2015
- Primary completion6 Dec 2016
- Study completion9 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Chronic Disease Control, India
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Science and Technology, Government of India, Jawaharlal Nehru Medical College
- Responsible party
- Principal investigator, Dr. Shweta Khandelwal, Centre for Chronic Disease Control, India
- Investigators
- Shweta Khandelwal, PhD, Principal investigator, Centre for Chronic Disease Control (CCDC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580345
- Sponsor's protocol ID
- SERC/LS-451/2011
- Acronym
- DHANI
- Status last verified
- Feb 2017
- First submitted
- 18 Apr 2012
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Khandelwal S, Swamy MK, Patil K, Kondal D, Chaudhry M, Gupta R, Divan G, Kamate M, Ramakrishnan L, Bellad MB, Gan A, Kodkany BS, Martorell R, Srinath Reddy K, Prabhakaran D, Ramakrishnan U, Tandon N, Stein AD. The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol. BMC Pediatr. 2018 Aug 4;18(1):261. doi: 10.1186/s12887-018-1225-5.
PubMed 30077178
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Docosa-Hexanoic Acid (DHA) Supplements During Pregnancy on Newborn Outcomes in India (DHANI)
- ClinicalTrials.gov ID
- NCT01580345
- Acronym / sponsor ID
- DHANI / SERC/LS-451/2011
- Conditions
- Pregnancy
- Keywords
- DHA, Omega 3 fatty acid, Decosa hexaenoic acid, Pregnancy, Newborn outcome, Supplementation, Birth size, gestational age
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Centre for Chronic Disease Control, IndiaUniversity, hospital or other
- Collaborators
- Department of Science and Technology, Government of India, Jawaharlal Nehru Medical College
- Study start
- Dec 2015
- Primary completion
- 6 Dec 2016 (actual)
- Study completion
- 9 Dec 2016 (actual)
- First posted
- 19 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The 'DHANI randomized controlled trial" seeks to examine the effects of prenatal DHA supplementation on newborn anthropometry where in healthy pregnant will be assigned to receive either 400 mg of DHA or a placebo daily from ≤20 weeks gestation through delivery.
Detailed description
A double-blinded, randomized, placebo controlled trial would be conducted among pregnant women in India to test the effectiveness of supplementing pregnant Indian women with 400 mg/d algal DHA compared to placebo from mid-pregnancy through delivery. Eligible participants would be randomized to receive either 400 mg of DHA or a placebo baseline measures would be taken before the enrollment of the participant in the study. This study would assess the effect of maternal DHA supplementation on:
- New born anthropometry (birth weight, length and head circumference)
- New born APGAR score
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docosa-hexaenoic Acid (DHA) | Active comparator | Dietary Supplement: Docosa-hexaenoic acid (DHA) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCorn-Soy Oil |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 to 35 year old pregnant women (singleton) at <=20 weeks of gestation (calculated from the LMP by study physician).
- Willing to participate in the study and perform all measurements for self, husband and the offspring including anthropometry, dietary assessment, questionnaires and biological samples (blood and breast milk).
- Willing to provide signed and dated informed consent.
Key exclusion criteria (5 listed)
- Women allergic (if aware) to any of the test products.
- Women at high risk for hemorrhagic bleeding, clotting (if aware).
- Women with high-risk pregnancies (history and prevalence of pregnancy complications, including abruptio placentae, preeclampsia, pregnancy-induced hypertension, any serious bleeding episode in the current pregnancy, and/ or physician referral); and/or diagnosed chronic degenerative disease(s) such as diagnosed heart disease, cancer, stroke or diabetes (as omega-3 could raise blood sugar and lower insulin production).
- Women consuming omega-3 supplements or having used these in 3 months preceding the intervention period.
- Reported participation in another biomedical trial 3 months before the start of the study or during the study (not to get the results of the present study contaminated).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docosa-hexaenoic acid (DHA)Also: DHA, Omega 3 fatty acid400 mg/day of Docosa-hexaenoic Acid (algal DHA) will given to the pregnant women (in the active group) from ≤20 weeks of gestation through delivery. | Dietary supplement | Docosa-hexaenoic Acid (DHA) |
| PlaceboAlso: Corn/Soy oil400 mg/day of placebo (corn/soy oil) will be given to the pregnant women from ≤20 weeks of gestation through delivery. | Dietary supplement | Placebo |
Primary outcome
Newborn anthropometry.
Time frame: At delivery
Measures for new born anthropometry would include birth weight, length and head circumference
3 secondary outcomes
Gestational age
Time frame: At delivery
New born APGAR Score
Time frame: At delivery (1 min and 5 mins)
Unfavorable pregnancy outcomes
Time frame: At delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Derived from this study: PubMed 30077178Khandelwal S, Swamy MK, Patil K, Kondal D, Chaudhry M, Gupta R, Divan G, Kamate M, Ramakrishnan L, Bellad MB, Gan A, Kodkany BS, Martorell R, Srinath Reddy K, Prabhakaran D, Ramakrishnan U, Tandon N, Stein AD. The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol. BMC Pediatr. 2018 Aug 4;18(1):261. doi: 10.1186/s12887-018-1225-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shweta Khandelwal, PhD principal investigator
Centre for Chronic Disease Control (CCDC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docosa-hexaenoic acid (DHA) in people with Pregnancy, run by Centre for Chronic Disease Control, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Newborn anthropometry. (time frame: At delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01580345, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017; AzTrials last refreshed its copy on 7 Nov 2026.